NCT04256785

Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia

Completed NA Results posted Last updated 2 August 2021

What this trial tests

NA trial testing VSL#3 in Fibromyalgia in 110 participants. Completed in 31 May 2020.

Timeline

11 May 2018

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	Elena Pita Calandre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	11 May 2018
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	1 location across Spain

Drugs / interventions tested

• VSL#3 — full drug profile →
• Placebo

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →
• Gastrointestinal Disease — all drugs for Gastrointestinal Disease →

Sponsor

Elena Pita Calandre

Who can join

18 and older, any sex, with Fibromyalgia or Gastrointestinal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale Primary · baseline and twelve weeks after treatment

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 12 score - baseline score)

Group	Value	95% CI
VSL#3	-6.5	± 9.5
Placebo	-5.4	± 6.6

Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR) Secondary · baseline and twelve weeks after treatment

The FIQR is a self-reported, validated questionnaire that evaluates the severity of fibromyalgia symptomatology in a scale ranging from 0 to 100 points; the higher the score, the worse the severity of the disease. Change = (week 12 score - baseline score)

Group	Value	95% CI
VSL#3	-7.2	± 12.5
Placebo	-12.5	± 14.1

Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI) Secondary · baseline and twelve weeks after treatment

The ISI is a self-reported, validated questionnaire that measures the severity of sleep disturbances in a scale ranging from 0 to 28 points: higher scores indicate more severe sleep disturbance

Group	Value	95% CI
VSL#3	-1.7	± 5.9
Placebo	-1.2	± 4.0

Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9) Secondary · baseline and twelve weeks after treatment

PHQ-9 is a self-reported, validated questionnaire that measures the severity of depression in a scale ranging from 0 to 27 points; higher scores indicate more severe depression. Change = (week 12 score - baseline score)

Group	Value	95% CI
VSL#3	-2.2	± 7.2
Placebo	-2.5	± 4.2

Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS Secondary · baseline and twelve weeks after treatment

The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score).

Group	Value	95% CI
VSL#3	4.5	± 8.0
Placebo	2.2	± 6.3

Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS Secondary · baseline and 12 weeks after treatment

The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score).

Group	Value	95% CI
VSL#3	0.8	± 12.4
Placebo	1.9	± 12.2

Number of Patients Considered as Responders to Treatment Secondary · Baseline and 12 weeks after treatment

Patients that showed at least a a 30% reduction in the score of the primary variable, i.e. the composite ccore of abdominal pain, abdominal bloating and metheorism each one measured in a 0-10 Visual Analog Scale, were considered as responders to treatment.

Group	Value	95% CI
VSL#3	27
Placebo	22

Change From Week 12 to Week 16 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment Secondary · Week 12 to week 16

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 16 score - week 12 score)

Group	Value	95% CI
VSL#3	2.0	± 5.2
Placebo	1.7	± 4.2

Change From Week 12 to Week 20 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment Secondary · Week 12 to week 20

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 20 score - week 12 score)

Group	Value	95% CI
VSL#3	1.0	± 3.7
Placebo	3.4	± 5.4

Change From Week 12 to Week 24 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment Secondary · Week 12 to week 24

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 24 score - week 12 score)

Group	Value	95% CI
VSL#3	1.3	± 3.6
Placebo	4.1	± 5.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VSL#3

Serious: 0/54 (0%)

Deaths: 0/54

Placebo

Serious: 0/56 (0%)

Deaths: 0/56

Other adverse events (13 terms — click to expand)

Reaction	System	VSL#3	Placebo
abdominal distension	Gastrointestinal disorders	—	—
flatulence	Gastrointestinal disorders	—	—
constipation	Gastrointestinal disorders	—	—
Upper abdominal pain	Gastrointestinal disorders	—	—
abdominal pain	Gastrointestinal disorders	—	—
Dispepsia	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
diarrhea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Disease worsening	General disorders	—	—
Swelling	General disorders	—	—
Influenza	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04256785 adverse events section.

Sponsor's own description

The study evaluated the efficacy and tolerability of probiotic VSL#3 for the treatment of gastrointestinal symptoms in patients with fibromyalgia; 50% of the participants received probiotic and the remaining 50% received matching placebo in a double-blind, randomized design.The treatment was administered during a 12-week period and the participants were followed for an additional 12-week period in order to follow the evolution after treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.